Endoscope Reprocessing: Guidance on the Requirements for Decontamination Equipment, Facilities and Management.

Transcription

1 Endoscope Reprocessing: Guidance on the Requirements for Decontamination Equipment, Facilities and Management. Note: This document provides interim guidance pending publication of the final version. Version 1.1 December 2004 (Amended September 2007) (See version control for changes)

2 Version Control Version 1.0 Issued December 2004 Version 1.1 Issued September 2007 Amendments The Idealised Schematics which were in Section 2.18 have been removed as these are under review. Exemplar layouts will be included in the web-based working draft of SHPN 13 Part 3, which will be available soon. If you require urgent advice on layouts please contact the Decontamination Team at Reference to Neighbourhood Decontamination Units has been removed as this concept is not being taken forward and will not be included in the revision of SHPN 13.

3 Contents Foreword 1. Introduction Fig 1 Flow chart - "Process Choices to Achieve Required Level of Decontamination" Fig 2 Process flow chart 2. Summary of requirements and methods of attainment 2.1 Records of endoscopes, EWDs and accessories 2.2 Acquisition of endoscopes, EWDs and ancillary materials 2.3 Processing environment 2.4 Decontamination processes 2.5 Choice of decontamination processes 2.6 Cleaning (including pre-cleaning) 2.7 Disinfection 2.8 Rinsing 2.9 Drying 2.10 Storage 2.11 Inspection and reassembly prior to use 2.12 Other processes - Sterilization 2.13 Transport of endoscopes before and after reprocessing 2.14 Traceability 2.15 Decontamination equipment - Manual cleaning equipment - Endoscope washer-disinfector - Drying / storage cabinet - Ultrasonic cleaner for re-usable accessories - Small steam sterilizer for re-usable accessories Summary of requirements and methods of attainment (continued) 2.16 Water supply 2.17 Repair, loan and disposal of endoscopes 2.18 Design of facilities 2.19 Management of decontamination 2.20 Health and Safety 2.21 Training 2.22 Quality management and Risk Management systems 2.23 Environment cleaning 3. References 4. Contact Details 5. Glossary of terms 6. Abbreviations and symbols Annex 1 Test programme for Endoscope Washer-disinfectors (EWDs) Annex 2 Test Methods and Requirements for EWDs Annex 3 Information to be supplied by the endoscope manufacturer Annex 4 Information to be exchanged prior to purchasing an EWD Annex 5 Process chemicals

4 Foreword This document has been prepared to provide guidance on the technical requirements for the decontamination of flexible endoscopes and the options available. The document is intended to summarise key information on best practice in a manner which is readily accessible to the user/manager. This guidance has been prepared by utilising published guidance from expert bodies, existing best practice guidance and standards, both published and in draft form. Many of the referenced standards are harmonised standards in respect of the Medical Device Directive. Information has been drawn from various expert groups and reference sources. These are referenced throughout the document. The principle sources are described below: - The Medical Devices Agency (MDA) (which has now been incorporated in the Medicines and Healthcare products Regulatory Agency) has published guidance on the Decontamination of Endoscopes (including MDA DB2002(05)). - The Joint Transmissible Spongiform Encephalopathy (TSE) Working Group of the Advisory Committee on Dangerous Pathogens and the Spongiform Encephalopathy Advisory Committee Joint Working Group (ACDP/SEAC JWG) has published guidance on safe working and prevention of infection relating to CJD and related diseases (see ) - Working Group (WG) 8 of CEN/TC102 and WG13 of ISO/TC198 is responsible for the preparation of a European /International standard on the requirements and tests for endoscope washer disinfectors, as the fourth part of the series of standards. The working draft has been circulated for public comment, a second public comment stage is anticipated later this year, with publication as a harmonised BS EN ISO standard under the Medical Devices Directive in The Scottish Health Technical Memorandum 2030 Washer-disinfectors (2001) includes guidance on the choice, specification, purchase, installation, validation, periodic testing, operation and maintenance of endoscope WDs; published by the Property and Environment Forum Executive. - The Health Technical Memorandum 2030 Washer-Disinfectors (1997) is published by NHS Estates. This document is substantially similar to SHTM 2030 but includes details of the microbiological testing required. - NHS Estates published a NHS Model Engineering Specification C32 Automated Endoscope Reprocessors for Flexible Endoscopes in The guidance of the Microbiology Advisory Committee to the Department of Health Medical Devices Agency (MAC Manual) Part 3, Section 2 offers guidance on sterilization and disinfection of endoscopes. - Guidance is also available from specialist professional bodies e.g. European Society for Gastroenterology ( British Society for Gastroenterology ( British Thoracic Society( See also Reference section. Decontamination practice in endoscopy, particularly given the thermolabile and complex nature of the target device, presents many challenges for cleaning and chemical disinfection. Those with responsibility for decontamination need to ensure that they are kept aware of current developments in a rapidly developing/evolving field. These include not only changes in the nature of decontamination equipment that may be available, the design and function of endoscopes etc but also includes changes in requirements in the light of new information about transmissible diseases. Within NHS Board Divisions in Scotland, overall responsibility for risk assessment and

5 management processes relating to decontamination, infection control, medical devices management and cleaning services is held by a senior manager designated by the Chief Executive, in line with HDL(2001)10. The Authorised Persons (Sterilizers) should be consulted for further detailed guidance and, in particular, guidance on the choice, validation, maintenance, testing and operation of decontamination equipment. This document has been drafted by staff at Health Protection Scotland (HPS, formerly SCIEH) and is currently subjected to review by relevant professionals in NHSScotland and the independent sector. 1. Introduction In 2003, the Sterile Services Provision Review Group (Glennie Group) recognised that there was a lack of guidance on the provision of decontamination facilities specifically for endoscopy. The Glennie technical requirements do not cover the decontamination of thermolabile endoscopes but are limited to those instruments where decontamination involves the application of heat disinfection and/or sterilization processes. It was recognised that, when designing endoscopy facilities and choosing equipment, it is important to be fully aware of the appropriate options. To assist in this, the Decontamination team of HPS / Decontamination Technical Advisory Panel (DTAP) has been commissioned to prepare guidance on behalf of the Glennie Group. Endoscopes and their accessories are classified as medical devices under the Medical Devices Directive (MDD). The essential requirements of this directive include: - that devices and manufacturing processes be designed to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties (Annex 1, paragraph 8.1); - that devices be designed, manufactured and packed in such a way as to minimise the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients (Annex 1, paragraph 7.2) Failure to adequately decontaminate flexible and rigid endoscopes between use may increase the risk of transmission of infection between patients and/or compromise the quality of clinical samples eg biopsy samples (ref HAZ(SC)04/05). The choice of appropriate decontamination process for devices used in a range of clinical procedures is typically based on the classification system first proposed by Dr E H Spaulding. The appropriate level of decontamination will depend on the procedure for which the endoscope is used (see Table 1) for example sterilization is the appropriate choice for arthroscopes used in critical procedures.

6 Table 1 Spaulding Classification applied to Endoscopy Classification Type of Procedure Appropriate Level of Decontamination Critical Semi-critical Invasive device enters tissue that is usually sterile or enters the vascular system. This includes contact with breaches in the skin and/or mucous membrane e.g. arthroscopes, biopsy forceps, papillotomes etc. Device contacts intact mucous membrane but does not penetrate sterile tissue; e.g. gastroscopes, colonoscopies. Sterilization High level disinfection Sterilization preferred where practicable. Non-critical Device only contacts intact skin e.g., stethoscope, sphygmomanometer cuff. Cleaning (and low level disinfection where necessary). A further limitation on the choice of decontamination process is the materials used for the construction of the flexible endoscope which are thermolabile (heat sensitive) or may be incompatible with specific process chemicals including the detergent for cleaning or the liquid chemical disinfectant. Concern about the risk of transmission of TSEs has led to specific recommendations for the decontamination of endoscopes used on symptomatic patients or on patients considered at risk of developing CJD. Attention is drawn to the current UK guidance from the ACDP-SEAC published on

7 Process Efficacy and Validation Endoscope Reprocessing: Guidance on the Requirements for Decontamination Equipment, Facilities and Management Endoscope decontamination involves a series of processes whereby the used device is cleaned, disinfected, rinsed and dried prior to its return fit for purpose to the clinical unit. Each process is subject to a number of variables, for example the nature and concentration of detergent, the volume, quality and temperature of the water and the physical energy applied in the cleaning process for each type of endoscope. Assurance of process efficacy cannot be given by simple visual inspection of the device before use it requires an understanding and control of these critical process variables. Manual processes have limited control and rely on operator training and careful adherence to agreed procedures to give any degree of consistency. In contrast, automated processing in an endoscope washer-disinfector (EWD) is capable of automatic control to pre-set specifications and of verification that the required standard is consistently met. This is the basis of the term validation a documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. Validation principles apply throughout the total decontamination process, beginning with the review of the specification against which the equipment is purchased. Evidence that the EWD has been designed and manufactured to the agreed specification should be provided as type test and works test data from the EWD manufacturer to the purchaser. Tests and checks are required on delivery ( installation qualification (IQ) and operational qualification (OQ) ) before beginning the detailed process of obtaining and documenting evidence that the EWD as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification. In effect, this means evidence that the EWD produces endoscopes that are cleaned and disinfected to the required standard a process described as performance qualification (PQ). Only after satisfactory completion of the stages up to performance qualification (also described as commissioning ) should the EWD be regarded as validated and acceptable for the decontamination of endoscopes in clinical practice. Performance is then monitored during routine use and by periodic tests, to ensure that the critical process control variables determined during performance qualification are still met. Tests are also required before an EWD is returned to service after repairs or modification that may have affected the process control. Four key aspects, embodied in the control protocols of SHTM 2030, ensure that the required standards of performance and safety are met: a) all EWDs are subjected to a planned programme of tests to validate their performance, that is to provide experimental evidence that, when operated under specified conditions, the WD will reliably produce cleaned and disinfected items to the standard required; b) all EWDs are subjected to a planned programme of tests to monitor their performance; c) all EWDs are operated in accordance with an agreed procedure by staff trained in the use of the WD; d) all EWDs are subjected to a planned programme of preventative maintenance irrespective of whether a preventative maintenance scheme is operated on the premises. Expertise in obtaining and recording the results of the planned programme of tests is provided by the qualified Test Person (TP(S)) and Maintenance Person (MP(S)). The test procedures and reports should be audited by the AP(S) who will provide interpretation of the test results for the User. The scheduled test programme includes simple routine tests to be undertaken by the operator as well as more complex validation and periodic tests to be undertaken by the TP(S) and MP(S). Schedules for type tests, pre-delivery works tests (when necessary), installation tests and checks, operational qualification, performance qualification and periodic tests are presented in Annex 1. The tests procedures, incorporating the tests proposed for the harmonised European standard for endoscope washer disinfectors (BS EN ISO ,4) are described in Annex 2..

8 Facilities for decontamination The document Local Decontamination Units: Provisional Guidance on the requirements for Equipment, Facilities and Management: recognizes three classes of decontamination unit: CDU - a central decontamination unit (sterile service department/unit) LDU - a local decontamination unit ERU - an endoscope re-processing unit Endoscopy re-processing unit (ERU) This is a unit set up to re-process only flexible, thermo-labile, usually fibre-optic, endoscopes and their accessories. The terminal decontamination process stage is high level disinfection using a liquid chemical disinfectant. Specialist endoscope washer-disinfectors (also described as automatic endoscope reprocessors) are used. An endoscopy reprocessing unit may be set up as an LDU, supplying only adjacent endoscopy clinics in the same building, or as a CDU. In addition it should be noted that, generally: the management and staff responsible for decontamination may have other eg clinical duties. an ERU may serve a single clinical speciality or several (eg linked to an operating theatre suite)in the same building. The nature of the terminal disinfection process means that the disinfected device is not packaged and protected against recontamination. The endoscope washerdisinfector should therefore be close to the point of use of the endoscope or careful measures should be taken to transport the decontaminated endoscope in a manner that does not compromise its status.

9 Decontamination in practice Endoscope Reprocessing: Guidance on the Requirements for Decontamination Equipment, Facilities and Management The following table summarises the essential requirements for endoscope decontamination. Function Equipment Facilities Staff Management Compliance with this document for manual cleaning. Requirements Compliance with SHTM 2030 and, when published, BS EN ISO ,4 for all endoscope washer-disinfectors in use. Effective separation of clean and dirty processes in accordance with the Local Decontamination Units: Guidance on the Requirements for Equipment, Facilities and Management All personnel carrying out decontamination processes have documented training needs assessment and record of training received, as part of a formal quality assurance system. Senior member of staff with documented responsibility for decontamination processes and capable of assessing and treating risks associated with ineffective decontamination processes. Senior Manager with overview in accord with HDL 2001(10) Compliance with the MDA Device Bulletin DB9801 Medical Devices and Equipment Management for Hospital and Community based Organisation The guidance that follows identifies and expands on the principles of decontamination that have been embodied in previous decontamination initiatives. Suggested methods by which these principles can be upheld and compliance achieved are provided. In providing guidance it is recognised that there is a need to provide: optimal methods applicable to new units; methods that can be applied to existing units that recognise the diversity of: - management arrangements; - location of decontamination activities; - clinical activity; - facilities and equipment; - policies, procedures and records; - staff training / competencies; - quality assurance; - resources. It is recognised also that different solutions may be required for different types of endoscopy practice and for different endoscopes.

10 Figure Figure 1: 1: PROCESS PROCESS CHOICES CHOICES TO TO ACHIEVE ACHIEVE REQUIRED REQUIRED LEVEL LEVEL OF OF DECONTAMINATION DECONTAMINATION Is the device designated by the manufacture as single use? Yes Do not reprocess* Has the device been, or is it to be used on a patient who has a definite/probable/possible diagnosis of CJD or is who is considered at- risk. No Can the device withstand steam sterilization (e.g.,134 o C for 3 mins cycle)? No Can the device withstand immersion in liquid and exposure to temperatures up to 100 o C? No Yes Yes Yes Contact the Infection Control Team and see current ACDP SEAC Guidance at Transfer to a central decontamination unit (CDU) for sterilization*. Reprocess in a validated instrument washer-disinfector* (ie thermal disinfection) preferably in a CDU. Can the device withstand immersion in Yes Yes Option 1 liquid at temperatures? 60 o C in an Is the equipment an endoscope WD providing Reprocessing in a validated endoscope WD* is the endoscope washer disinfector (WD)? both cleaning and chemical disinfection cycles? preferred option to achieve high level chemical disinfection. See Fig 2 Process Map. No No No Is an automated As soon as possible: endoscope reprocessor -replace with immersible endoscope; available? -provide an endoscope WD as appropriate. Can manual chemical Yes disinfection be undertaken to Can the device withstand total the appropriate standard and immersion in chemical disinfectant? in a manner consistent with the COSHH assessment? No Either withdraw endoscope from use or reprocess via an ethylene N.B. Disposable sheaths are oxide sub-contractor. available for for non-lumened nasendoscopes Option 2 Yes Reprocessing in a validated endoscope reprocessor* with only a If If there are insufficient irrigation chemical disinfection capability is an ports available for for the endoscopes alternative option thorough pre- being reprocessed, as as a temporary cleaning is essential. See Fig 2 measure until suitable equipment Process Map. can be be obtained and, if if consistent with the COSHH assessment, Yes manually disinfect and rinse Chemically disinfect manually*, channels that cannot be be but be aware that this is the least decontaminated, prior to to placing satisfactory option for chemical endoscope in in the automated disinfection and that the process reprocessor. cannot be validated. N.B. THIS IS ONLY A QUICK GUIDE REFER TO MAIN TEXT FOR DETAILED GUIDANCE. *Choices must be based on information provided by manufacturers.

11 Figure 2: ENDOSCOPE DECONTAMINATION PROCESS MAP (Elements of the decontamination process will vary dependent on the type of endoscope) Remove endoscope from patient Remove gross contamination by wiping outer surface and flushing all channels before endoscope is detached from the light source/video reprocessor. Discard used brushes into clinical waste Discard single-use accessories. Transfer re-usable accessories e.g., biopsy forceps, steam sterilizable components to container for transfer for decontamination. Transfer relevant components to ultrasonic bath Ultrasonicate Immediate transfer to clinical area for use Check for cleanliness and re-assemble prior to use Add single-use and sterilized items Consider type of endoscope - is brushing of channels/leak testing required at this stage? Transfer endoscope out of clinical area and into the decontamination area No Brush all channels as required (use single-use brushes) Dismantle scope Consider treatment required for component parts Test channel patency and leak test Manually pre-clean endoscope Brush and flush with detergent solution Rinse to remove detergent Transfer to Endoscope Washer Disinfector (EWD) Connect all channels to EWD irrigation ports Select and initiate operating cycle Is manual drying stage required? ENDOSCOPE READY FOR USE Re-process after storage before use. Yes No Was storage in HEPA filtered cabinet, and duration <72 hours Transfer to storage cabinet Purge with air then 70% alcohol (follow manufacturers instructions). Can be used if necessary without further re-processing Yes CLINICAL AREA ENDOSCOPE REPROCESSING UNIT

12 2. Summary of requirements and methods of attainment Note: In the tables below where various options are given for methods by which the requirements may be met the options are numbered in order of preference. Where the options are un-numbered there is no preference for which method should be adopted. 2.1 Records of endoscopes/ EWDs/accessories Para Principle Methods to Achieve Explanatory Notes / Reference An inventory should be maintained of all the endoscopes available for use, their location/s for use and the location/s for reprocessing. List to include: Manufacturer Supplier Model Number Serial number Type of endoscope Date of purchase Asset Number Location List the ownership status of the endoscope (eg owned by Health Board or equivalent, on loan or borrowed from another site). Maintaining detailed records should ensure that the actions required in respect of hazard notices (eg the recent Medical Device Alert MDA 2004/028 Hazard Notice HAZ(SC)04/05) and similar information / updates from manufacturers can be addressed for specified models in a timely manner. Maintaining local detailed records, for example serial numbers for traceability and asset register records for maintenance/procurement should ensure effective endoscope management All endoscopes and endoscope WDs should meet the essential requirements of the Medical Device Directive. Endoscopes and endoscope WDs purchased after 13/06/98 should bear the CE mark and should be manufactured to meet the requirements of the appropriate harmonised European standards under the Medical Device Directive. Devices including endoscopes purchased prior to that date, without a CE mark, should be phased out of use. Endoscopes are classified as medical devices under the Medical Device Directive. Endoscope WDs are also classified as medical devices under the MDD, given their specific purpose for the disinfection of medical devices. The Official Journal of the European Community (OJEC) gives the formal reference for harmonised standards under the Medical Device Directive.

13 2.1 Records of endoscopes/ EWDs/accessories (continued) Para Principle Methods to Achieve Explanatory Notes / Reference All re-usable endoscopic devices including accessories that are currently in stock should be capable of being decontaminated by an available and agreed decontamination processes. Review the endoscope manufacturer s instructions for all reusable endoscopes and accessories currently in stock. Review the endoscope decontamination policy established for the site, to determine how the manufacturer s instructions will be implemented. Review the available decontamination capability and plan the necessary resource. Instructions for the reprocessing of a device are required from the device manufacturer under the Medical Device Directive. Copies of these instructions should be available in the endoscope reprocessing unit (ERU). A site-specific, local policy for endoscope decontamination (including choice of process chemical, reprocessing facilities and equipment) should be established.

14 2.2. Acquisition of endoscopes, endoscope WDs and ancillary materials Para Principle Methods to Achieve Explanatory Notes / Reference General The procurement of endoscopes, accessories and endoscope reprocessing equipment should be to agreed specifications, with prior consideration of decontamination issues and that should comply with the documented purchasing policy. Agree a documented purchasing policy. Record the consultation process involving appropriate specialists, to include: - endoscopy staff; - procurement / purchasing; - infection control team - Medical and Nursing Directors, - estates / engineering; - sterile services department; - medical physics; - risk management, - Authorized Person (Sterilizers); - Microbiologist (Sterilizers). Consult the AP(S) for guidance on the specification of the equipment used for the decontamination of endoscopes and their accessories. General advice on purchasing equipment within the NHS is given in MDA DB 9801 February 1999 Medical Device and Equipment Management for Hospital and Communitybased Organisations. SHTM 2030 Design Considerations gives an overview of procurement of a WD, specification and contract (sections 2.0, 3.0 and 4.0) and more detailed guidance on the specification for endoscope WDs in section The draft BS EN ISO and gives specific guidance on the specification of endoscope WDs. See also Annex 4 in this document Prior to purchase, it should be established that all reusable endoscopes are capable of being decontaminated by an available decontamination process. The documented policy for purchasing re-usable devices should include a review of the endoscope manufacturer s instructions in conjunction with the local endoscope decontamination policy. For devices not previously purchased a full specification may be required. Replacement of previously purchased devices may only require an unambiguous reference for the supplier Sufficient endoscopes should be available to allow the necessary time for re-processing without adversely affecting throughput. Review clinical demand versus device stock and the time required for reprocessing; allowing time for necessary maintenance and repair. Establish and maintain stocks to the required level.

15 2.2. Acquisition of endoscopes, endoscope WDs and ancillary materials (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Single-use components and accessories should be used. Review the endoscope manufacturer s information on the accessories and components available for the specific endoscope. (1) Use single-use components and accessories. (2) Use re-usable accessories that are capable of being sterilised by steam. MDA DB2002(05) states that where practicable, singleuse devices should be used. NHS MEL (1999) 65, advising on minimising the risk of transmission of vcjd, states that where there are practical options for using single-use instruments, which do not compromise clinical outcome, consideration should be given to using these for surgical procedures. The BSG Working Party (2003) specifies particular components and accessories that should be considered as single use only. These include endoscopic biopsy forceps and brush-tipped wires used for manual cleaning. Rubber biopsy valve channel caps should be discarded after any endoscopic procedures that involve passage of biopsy forceps or other accessories through the valves (Recommendation 9, BSG 2003). The ACPD/SEAC in their TSE guidance, Annex F, on decontamination of endoscopes (Sept 2004) state the channel cleaning brushes and the valve on the biopsy/instrument channel port used with flexible endoscopes should be disposed of as clinical waste after each use.

16 2.2. Acquisition of endoscopes, endoscope WDs and ancillary materials (continued) Para Principle Methods to Achieve Explanatory Notes / Reference There should be sufficient EWDs to meet the needs of the respective endoscopy department. Calculate the requirement for EWDs in a particular unit based on current and planned clinical need, the number of endoscopes and the minimum time required for the endoscope decontamination process. Detailed guidance on how to determine the required EWD capacity is given in SHTM A check list is also provided in the ESGE/ESGENA Guidelines 2000 for this purpose, requiring data on: - how many endoscopic interventions are performed in the endoscopy department per year; - how many endoscopic procedures are on each list per day (average); - what type of procedures are offered in the department and with which frequency; - how many procedure rooms the endoscopy unit has, if simultaneous working in different endoscopy suites is possible and in how many rooms; - how many endoscopy reprocessing rooms/ ERUs the unit has; - how many staff are available for reprocessing endoscopes and equipment; - how much time is scheduled for reprocessing a flexible endoscope.

17 2.2. Acquisition of endoscopes, endoscope WDs and ancillary materials (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Means should be provided to ensure that the EWD, as designed and manufactured, is fit for its intended purpose Prepare a detailed specification, based on the reprocessing needs of endoscopy and including the type, model number and any design features relevant for decontamination for each endoscope that the EWD is intended to process. Specify a requirement for compliance with BS EN ISO ,4 (when published) and BS EN ISO Prior to publication of BS EN ISO 15883, compliance with the design specification in SHTM should be stated. The specification should be prepared by the User with input from other key personnel including the AP(S). General guidance on drawing up the specification and contract is given in SHTM , section 4. See also the NHS Estates publication Model Engineering Specification C32 Automated Endoscope Reprocessors for Flexible Endoscopes (2003) The EWD should be manufactured in a manner that will ensure its quality and conformance to specification. The EWD manufacturer should ensure that the EWD is designed, manufactured and tested within a quality system complying with the requirements of BS EN ISO BS EN ISO describes a quality management system applicable to medical device decontamination. See Means should be provided to ensure that the particular EWD as delivered and installed on site is fit for purpose. Subject the EWD to a planned programme of testing both before delivery and on-site, using the procedures described in Annex 1 and 2. These should include installation qualification, operational qualification and process qualification (see below) and should include also tests and checks carried out during manufacture. See Annex 1 and 2.

18 2.2. Acquisition of endoscopes, endoscope WDs and ancillary materials (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Works tests should be undertaken to establish that the EWD meets the performance standards established during type testing. Before delivery of the EWD, the manufacturer should subject the machine to a programme of factory tests. It is rarely necessary to attend the factory to witness works tests but the manufacturer should make the results of these tests available on or before delivery of the WD. The EWD Manufacturer should carry out pre-delivery works testing. The extent of testing will depend on whether the product is in serial production or a oneoff and, for machines in serial production, whether the manufacturer has obtained a certificate of compliance to a relevant British or European Standard by means of a type test for the particular type and size of EWD. See schedule for type tests and works tests in Annex 1 and Pre-installation checks should be undertaken to establish that the area in which the EWD is installed and the quality / quantity of all services are to the required standard. The contractor should verify that the site services are adequate for the operation and performance of the WD before it is delivered. The contractor should verify the condition of the water supply and set chemical dosing levels as appropriate. Guidance is given in SHTM , Section 2. For example, the EWD may require ancillary equipment such as water softeners, deionization or reverse osmosis (RO) water treatment plant, extract ventilation (with or without condensers), bulk storage and dispensing facilities for process chemicals including chemical disinfectants. Such requirements have implications for the space and services required and the overall design of the ERU.

19 2.2. Acquisition of endoscopes, endoscope WDs and ancillary materials (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Installation tests should ensure that the equipment is properly connected to all services and is safe to operate. The contractor, who may also be the manufacturer, should complete the installation checks and tests specified in SHTM to the satisfaction of the MP/TP before the WD can be accepted for use in accordance with the contract. The contractor should provide the test instruments and equipment (but unless otherwise specified in the contract, should not be expected to provide the test loads). The test instruments provided should meet the standards for test instruments described in SHTM The contractor should carry out the required installation checks on delivery of the WD to ensure the WD has been supplied and installed correctly and is safe to operate. Ventilation systems should be checked by the contractor responsible for their installation. When the checks have been completed and found satisfactory the contractor should carry out the installation tests necessary to demonstrate that the WD is working satisfactorily. Any assistance required from the purchaser should be agreed as part of the purchase contract. See Annex 1 and Acceptance of the installation should be based on the test data generated after any required changes have been made at the installation site. If any modification, maintenance or repair work is carried out for example on the water, compressed air ventilation or drainage systems after the installation tests have been completed, the relevant installation tests should be repeated before the operational tests are undertaken.

20 2.2. Acquisition of endoscopes, endoscope WDs and ancillary materials (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Operational qualification tests should ensure that the EWD functions correctly. When the EWD has been installed and accepted, the See Annex 1 and 2. MP/TP should carry out a sequence of operational qualification tests to evaluate the basic performance and safety of the EWD. Some of these tests are identical to those specified as installation tests and need not be repeated if operational testing follows within ten working days of the completion of the installation tests Performance qualification tests should ensure that the EWD produces endoscopes that are cleaned and disinfected to the required standard Ancillary materials (Process chemicals, process indicators etc) All ancillary materials should be appropriate for their intended use. When the operational qualification tests have been completed and accepted, the MP/TP should undertake a sequence of performance qualification tests to show that: - soil removal and cleaning have been effective throughout the load and the WD chamber and that the product is of the required standard of cleanliness, free from process residues (where applicable); - disinfection conditions have been attained throughout the load and the WD chamber and to the required standard for the type of load being processed. Purchase from reputable/ approved suppliers. Purchase to relevant BS EN specifications. Review the device manufacturer s instructions for compatibility. Review of decontamination equipment manufacturer s instructions for compatibility. See Annex 1 and 2. Process chemicals should be chosen to ensure that they are compatible with the medical devices to be processed, the decontamination equipment to be used and the process in which they will be employed. Care should be taken to ensure that the facilities available are appropriate for storage, use and disposal of the process chemicals, particularly when toxic or noxious chemicals are involved.

21 2.2 Acquisition of endoscopes, endoscope WDs and ancillary materials (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Process chemicals Means should be provided to ensure that the process chemicals are fit for their intended use The use of process chemicals should not be extended beyond the active life stated by the manufacturer. Obtain information for each specific process chemical to be used, concerning: Compatibility - with other process chemicals - with the endoscope - with the EWD Toxicity profile for - staff - the environment - patients Packaging - presentation - labelling Storage Shelf-life Antimicrobial efficacy - range of microorganisms - lethal rate Conditions of use (concentration / temperature / time) Evidence that the process chemical has been validated for use in the specific EWD. Ensure that all process chemicals, in manual and automated processes, are prepared, used and discarded according to the manufacturer s instructions. Use single-shot disinfectants in preference to multi-dose formulations. This information may be obtained from various reference sources including the Material Safety Data Sheet provided by the process chemical manufacturer. Evidence that the process chemical has been validate for use in the specific EWD should be provided by the EWD manufacturer. Further guidance should be sought from the: manufacturer of the device to be decontaminated; Microbiologist (Sterilizers); Safety Officer; AP (S). Indicators are available to monitor the process eg cleaning efficacy or to monitor the concentration of an active chemical such as the concentration of disinfectant. The latter option is not available for all disinfectants. The disinfectant manufacturer may give an indication of the period of time during which a chemical solution may be reused. Such information will be modified by many local factors, such as the individual practice, inactivation by soiling on the device, dilution in the EWD etc. Re-use of disinfectant solutions gives a variable, nonquantifiable product (ie a non-validated process) and may compromise the efficacy of the disinfection process.

22 2.3 Processing environment Para Principle Methods to Achieve Explanatory Notes / Reference The decontamination process should have no adverse effect on the clinical environment. (1) Physically segregate the decontamination processes that have the potential to contaminate the clinical environment eg a designated decontamination area / ERU separated from the patient treatment area by means of a wall. Physical segregation would require those decontamination processes that may contribute to contamination of the environment (eg dis-assembly and cleaning of used devices) to be carried out in a separate room (2) Provide mechanical ventilation and designated work stations to ensure that the flow of any contamination arising from the decontamination process will be away from the patient area The decontamination process should have no adverse effect on staff or third parties. Physically segregate decontamination processes that have the potential to contaminate the external environment. Restrict access to the decontamination area /ERU where these activities are carried out Provide appropriate PPE to staff within the decontamination area. See Annex on Ventilation in Local Decontamination Units: Guidance on the Requirements for Equipment, Facilities and Management. Decontamination should not be carried out in public access areas, corridors etc. Access to the decontamination area /ERU should be restricted to staff who have received appropriate training Elements of the decontamination process for one device should have no adverse effect on other medical devices. (i) Physically segregate dirty decontamination processes (such as manual pre-cleaning) from the inspection/storage of the reprocessed device. (ii) Provide mechanical ventilation and designated work stations to ensure that the flow of any contamination arising from the decontamination process will be away from disinfected/ reprocessed device.

23 2.4 Decontamination processes Para Principle Methods to Achieve Explanatory Notes/ Reference Decontamination processes should ensure that: Ensure that all aspects of the decontamination process are controlled, to include: - design of decontamination equipment and at the point of use, reprocessed devices are processes; free from: - choice of process chemicals; - residues of previous procedures; - quality of water used in decontamination - residues from the decontamination process; process; - environmental control; - adventitious contamination eg particulates and other environmental - use of appropriate cleaning and disinfection contaminants; methods; - microbial contamination. - appropriate transport systems; - validation, testing and record keeping.. Removal of contamination present from previous use of the device is best assured by the use of effective, validated, cleaning processes in an automated EWD. Manual pre-cleaning will also be required. The choice of process chemicals will affect both the cleaning efficacy and the ease with which process residues may be removed. Only free rinsing detergents should be used; surgical hand scrubs are not a suitable substitute. The quality of water used for the final rinse will also affect the extent of process residues; hard water will leave limescale deposits. Control of adventitious contamination from the environment may be achieved by physical segregation from sources of contamination, ventilation to move airborne contaminants away from the device and appropriate environmental cleaning. Evidence of the required standards of decontamination can only be achieved through keeping records of appropriate testing, monitoring, maintenance and operation of the decontamination equipment there is evidence of attainment of the required standards of decontamination. Keep all records of the testing, monitoring, maintenance and operation of the decontamination equipment available in the ERU. Other departments such as Estates, Medical Physics or sub-contractors eg EWD manufacturer test persons may also hold test records. These records/reports should be available to the User. They provide an essential history of the equipment s performance and reliability. All such records should be available for internal and external audit as required.

24 2.4 Decontamination processes (continued) Para Principle Methods to Achieve Explanatory Notes/ Reference Decontamination processes should ensure that Use decontamination equipment that is designed and constructed to prevent environmental the decontamination process is designed dispersal of contamination from devices being and carried out in a manner that minimises reprocessed. the risk of recontamination of clean devices. The design and construction requirements for EWDs to ensure that the door does not leak or generate aerosol contamination are given in BS EN Ultrasonic cleaners should only be operated with the lid in place Use techniques that minimise the generation and dispersal of environmental contamination eg aerosols Physically segregate those elements of the decontamination process dealing with contaminated devices and those dealing with cleaned/disinfected devices. Manual pre-cleaning procedures should be carried out with the device immersed. Inspection, drying and storage of reprocessed endoscopes are clean procedures. The arrangements for decontamination in the ERU should ensure that they cannot become contaminated by used devices or the precleaning process Provide a linear work flow and extract ventilation to ensure that the flow of any contamination arising from the decontamination process dealing with contaminated devices will be away from cleaned/disinfected devices. A work flow plan should be established showing a logical progression from dirty to clean without the possibility of cross contamination. The plan should clearly identify the pathway to introduce clean decontaminated supplies and the pathway to remove contaminated waste for safe disposal. Further guidance on ventilation is given in the LDU guidance document.

25 2.5 Choice of decontamination processes Para Principle Methods to Achieve Explanatory Notes / Reference Decontamination processes should be chosen to be: effective for the device to be processed. Refer to the endoscope manufacturer s instructions for reprocessing. Refer to the EWD manufacturer s type test data or information supplied to confirm that the requirements for reprocessing (channel irrigation, temperature control etc) are met for the specific device. If the available information is inadequate and cannot be remedied by recourse to other reference sources or requires a process or a level of complexity of equipment which is not available on the site, then the preferred option is to withdraw the device from use until such time that any omissions can be remedied. Substitution of an alternative decontamination method from that given by the endoscope manufacturer and without appropriate validation should only be made on the understanding that the User/Management now assumes liability for the microbial quality and function of the reprocessed device. Manufacturers of reusable medical devices are required to give instructions for reprocessing, under the MDD. See also BS EN ISO Manufacturers of EWDs are required to provide evidence of the validation of their process for specific (named) types or families of endoscope. Users may also seek advice from the manufacturers of the chemical disinfectant, the AP(S), the Infection Control team and from national reference centres such as HPS Compatible with the devices to be processed. Refer to information provided by the endoscope manufacturer. Refer to information provided by the process chemical (detergent and disinfectant) manufacturers instructions. Evidence of the compatibility/incompatibility of a particular manufacturer s device and the process chemical requires precise investigation, typically by the endoscope manufacturer. Prior to the release of such evidence, an assumption may be made by the User from observations in practice. Caution should be applied to such interpretations and emphasis should be placed on thorough rinsing of all process chemicals from the surfaces of the device.

26 2.5 Choice of decontamination processes (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Decontamination processes should be chosen to be: Capable of providing the level of decontamination required for the clinical procedures to be undertaken. Refer to device manufacturers instructions. Refer to the local decontamination policy. Practice example: A compromise two tier system for non-lumened endoscopes where there are time constraints and difficulty with immediate access to a endoscope WD is: At the beginning and end of each day reprocess the scope in an endoscope washer disinfector. Between patients: - use a disposable sheath over scope for each patient; - wipe over scope with a detergent and water solution, - rinse to remove detergent residue; - wipe over with alcohol. The undernoted provisos apply: The integrity of the disposable sheath should be checked at the end of the procedure (fill with water and check for leaks). If the sheath is not intact the scope should be reprocessed through a washer disinfector. If the procedure becomes inadvertently invasive, the scope should be reprocessed through a washer disinfector. See Spaulding classification (Introduction, Table 1). This classification should be used to inform the choice of process appropriate for the level of risk and the tolerance of the equipment. This should be documented and available to staff within the ERU.

27 2.5 Choice of decontamination processes (continued) Para Principle Methods to Achieve Explanatory Notes / Reference Capable of ensuring freedom from contamination that could lead to an erroneous diagnosis. Ensure that the EWD is subject to a self-disinfection process, in line with the EWD manufacturer s instructions. Contamination of endoscopes, particularly bronchoscopes, with environmental mycobacteria have led to the misdiagnosis of mycobacterial infection. The contamination has arisen from a variety of sources including mains water used for the final rinse and from contaminated foci within the endoscope and the EWD Appropriate for the environment available for decontamination processing. Design and operate the ERU to ensure a safe working environment, compatible with the chosen method of segregating dirty and clean devices Capable of providing the throughput required to maintain the desired level of clinical service. Refer to the planning calculations made in determining the EWD requirements for a particular ERU and revise in response to any changes, for example increased clinical need. See 2 2.6